Getting Started
Start analyzing medical devices with AI in just a few minutes
Quick Start Guide
Create Your Account
Sign up using your email address. We'll send a verification link to confirm your account.
Go to Sign UpChoose Your Analysis Type
From the dashboard, select the type of analysis you need:
FDA Filing
For regulatory submissions
Operations
For performance analysis
Monitoring
For real-time surveillance
Try a Demo or Upload Your File
Start with our pre-loaded demo documents to see how the system works, or upload your own files.
Demo Documents Available:
- • Cardiac Pacemaker 510(k) submission
- • Ventilator performance logs
- • MRI scanner maintenance records
Review AI Analysis
Watch as our three AI agents analyze your document in real-time. You'll receive individual scores and a consensus recommendation with specific action items.
Your First Analysis
We recommend starting with a demo document to familiarize yourself with the platform:
Recommended: FDA Filing Demo
- 1.Navigate to Dashboard → FDA Filing Analysis
- 2.Click on "Cardiac Pacemaker 510(k)" demo document
- 3.Click "Preview Document" to see the full submission
- 4.Click "Start AI Analysis" to begin
- 5.Watch the progress bar and agent status updates
- 6.Review the consensus score and recommendations
Expected Result: You'll see an approval likelihood score of 87% with specific recommendations from each agent.
Understanding Your Results
Agent Scores
Each agent provides a score from 0-100% based on their specialized analysis:
Consensus Score
The final score is a weighted average that prioritizes patient safety while considering operational efficiency and regulatory compliance. This balanced approach ensures no critical aspect is overlooked.
Recommendations
Each agent provides specific recommendations. Focus on items marked as "Critical" or "High Priority" first, as these have the greatest impact on your approval likelihood or device performance.
Common Questions
How long does analysis take?
Most analyses complete in 2-5 minutes. FDA filings typically take longer than operational logs due to document complexity.
Can I analyze multiple files?
Yes, you can run multiple analyses. Each analysis is saved in your dashboard for future reference and comparison.
Are my documents secure?
All documents are encrypted in transit and at rest. We comply with HIPAA and FDA data security requirements.
Can I export results?
Yes, analysis results can be exported as PDF reports or accessed via our API for integration with your quality management systems.
Ready to Start?
Begin with a demo analysis to see Deffai in action.